SCANDARE TNBC WGS data

RESEARCH DATA TRANSFER AND USE AGREEMENT BETWEEN Institut Curie Foundation of public interest 26, rue d’Ulm – 75005 Paris Represented by Mr. Thierry Philip, President, and by delegation, by Mr. Amaury Martin, Director of technology transfer and industrial partnerships office, Hereinafter designated as "Institut Curie", ON THE ONE HAND, AND XXXX, …………… company, registered with the companies registry (RCS) in ………………, headquartered at …………………………, represented by ……………, …………………, Hereinafter designated as "User Institution", User Institution and Registered Users (as defined at Article 2) are hereafter collectively referred to as “User” ON THE OTHER HAND, Designated, collectively or not, as the "Party/Parties". The present agreement (“Agreement”) governs access to the managed access datasets (details of which are set out in Articles 1 and 2) to which the User has requested access. The User Institution agrees to be bound by the terms and conditions of the Agreement. ARTICLE 1 – INFORMATION RELATED TO THE DATA : Names of Data producers/collaborators (if any) Dr Edith Borcoman (PI SCANDARE) Specific limitations on areas of research SCANDARE ovarian WES data : SCANDARE (NCT03017573) is a multicentric biobanking study, enrolling adult patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), ovarian and cervical cancer. Study ID : EGAS50000001161 Minimum protection measures required In order to avoid inadvertent disclosure of EGA Controlled Data to unauthorized individuals, we ask that you observe basic information security practices. If you make local copies of EGA Controlled Data, You must minimize the risk that this information might be used and/or disclosed to persons who have not been approved for access to EGA Controlled Data. At a minimum, You agree to the following: • Physical security – EGA Controlled Data will be maintained on physically secure computer systems, such as in a locked office. If the data is stored on a laptop computer, it must be encrypted to avoid its disclosure in case of loss or theft. • Access security – Only individuals who are listed on in this application will have access to ICGC Controlled Data. If copies of the EGA Controlled Data are stored locally on a shared computer system or a file server, then they must be strong password and/or encryption protected so that only the individual’s named in the application have access to it. If the computer that holds EGA Controlled Data is backed up, the backup media must be encrypted and/or stored in a physically secure location. • Network security – If EGA Controlled Data are stored on a network-accessible computer, there must be controls in place to prevent access by computer “hackers”, or contamination by viruses, malware and spyware. Network security is usually implemented by Your institution's IT department and will consist of some combination of network firewalls, network intrusion monitoring, and virus scanning software. • End of project – After finishing the Research Project for which you are requesting access or if Your access approval is terminated, You must securely destroy all local copies of the EGA Controlled Data, including any backups copies. However, if necessary, you may still keep the EGA Controlled Data for archival purpose in conformity with national audits or other legal requirements. • Training – Everyone who will access and/or use EGA Controlled Data must be trained in the responsible use of personal health information, familiarized with the terms and conditions of the Data Access Agreement, and briefed on Your security plans. • Compute Cloud Use – You may place copies of EGA Controlled Data on a private or commercial compute cloud for analytical purposes. If You do so, You acknowledge that You maintain responsibility for the data and You agree that: You must take care to apply strong encryption to the data while in motion and at rest; restrict access to stored copies of the data to Yourself, authorized personnel, students and authorized collaborators; use firewall rules to restrict ingress and egress from virtual machines to trusted network address(es) keep virtual machines that host controlled data up to date with security patches; and destroy all copies of the data, including snapshots and backups, at the end of the Research Project or if Your application is not renewed; and ensure there is an agreement in place with Your cloud provider that ensures You can meet these requirements. Any use of a private or commercial cloud is between You and the cloud provider. To the extent permitted by law OICR accepts no responsibility for any interaction between You and the cloud provider and is released from any liability arising out of or in any way connected with such interaction. ARTICLE 2 – INFORMATION RELATED TO THE USER (to be completed by the User) Brief abstract of the project in which the Data will be used (500 words max) (the “User Project”) All Individuals, User Institution’s employees only, needing to have access to the DATA within the framework of the Project (“Registered Users”): Name of Registered Users Email Job Title Supervisor Principal Investigator : All Registered Users having an account created at the EGA : Name of Registered User Email Job Title The User Institution will notify Institut Curie within 30 days of any changes or departures of the Registered Users. ARTICLE 3 –USE OF DATA 3.1. Use of Data. The User will use the Data only in the performance of the User Project and for no other use without the written approval of Institut Curie and execution of an amendment to this Agreement. 3.2 Permitted Users. The Data will be used solely by Registered Users and those under their direct supervision who are User Institution’s employees (the “Authorised Personnel”). 3.3 No Transfer. Except as specifically provided herein, User will not distribute or transfer the Data to any other investigator at the User Institution or to any third party, for any reason without the prior written consent of an authorized representative of Institut Curie. 3.4 No Commercial Use. The User Project is a research that is seeking to advance the understanding of genetics and genomics, including the treatment of disorders, and work on statistical methods that may be applied to such research. The User Project does not include commercial use and/or commercial purpose. User will not use the Data in any research that is subject to consulting or licensing obligations to any for-profit organizations. 3.5 The User Institution will notify Institut Curie as soon as it becomes aware of a breach of the terms or conditions of this Agreement. 3.6 The User Institution agrees to distribute a copy of these terms to the Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this Agreement. ARTICLE 4 - CONFIDENTIALITY 4.1 User agrees to maintain the confidentiality of the Data for the entire duration of this Agreement and for five (5) years thereafter. In addition, User agrees not to use, except as needed for the purposes of this Agreement, any Confidential Information without first obtaining the written consent of Institut Curie. However, User shall not have any obligation to Institut Curie with respect to information which: a) is or later becomes generally available to the public by use, publication or the like, through no fault of User; or b) is obtained from a third party who had the legal right to disclose the same to third parties; or c) is already in the possession of user at the time of disclosure, as evidenced by the parties business records; or d) is required to be released under law or court order, provided that User gives all reasonable prior notice to Institut Curie to allow it to seek protective or other court orders. For the avoidance of doubt, "Confidential Information" designates any document and/or data, software and/or material, samples, models, methods, descriptions, know-how, processes, patentable or non-patentable applications and/or knowledge, in any form and of any kind, regardless of the medium and means used for their communication, disclosed by one Party to the other Party under the Agreement. 4.2 User undertakes not to use, or attempt to use the Data to compromise or otherwise infringe the confidentiality of information on Research Participants (individuals whose data form part of the Data). ARTICLE 5 - INTELLECTUAL PROPERTY 5.1 Ownership. User acknowledges that the Data constitutes background intellectual property of Institut Curie and that Institut Curie retains title and all rights in the Data. User agrees not to make intellectual property claims on these Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of these Data, or conclusion drawn directly from these Data. No right or license is granted by Institut Curie under this Agreement, either expressly or by implication, except those set forth therein. It is understood that all rights, included but not limited to patent rights, trademarks and proprietary rights to the Data shall be and remain vested in Institut Curie, subject the rights granted herein. Nothing in this Agreement shall restrict Institut Curie’s use of Data in any way it wishes, or to distribute the Data to other commercial of non-commercial entities. 5.2. Results. In the event the User Project results in an invention, improvement or substance, whether patentable or not (“Results”), User agrees to disclose it promptly to Institut Curie in order for the Parties to negotiate, when appropriate and in good faith, suitable agreements that shall provide for further developments of said Results. ARTICLE 6 – PUBLICATIONS User is free to publish its results of the User Project subject to the terms of this Agreement. In accordance with scientific custom, User agrees to recognize the contribution of Institut Curie through acknowledgement and citation of the manuscript reporting the Data. In any publications based on these Data, User shall describe how the Data can be accessed, including the name of the hosting database (e.g., The European Genome-phenome Archive at the European Bioinformatics Institute) and its accession numbers (e.g., EGAS00000000029), and acknowledge its use in a form agreed by the User Institution with Institut Curie. ARTICLE 7 - TERM AND TERMINATION 7.1 Term. The Agreement shall begin on its date of signature by both Parties (the “Effective Date”) and shall expire upon completion of the User Project (the “Term”) unless earlier terminated pursuant to this Article 7. 7.2 Termination. Either Party may terminate this Agreement with or without cause at any time upon the receipt of thirty (30) days prior written notice to the non-terminating Party. 7.3 Effect of Termination. User agrees to destroy the Data and all copies thereof upon termination of this Agreement, unless obliged to retain the data for archival purposes in conformity with audit or legal requirements. User will provide prompt written notice of such destruction. 7.4 Survival of Obligations. The rights and obligations that would, by their nature, survive expiration or termination of this Agreement (notably confidentiality obligation) or that have accrued prior to termination shall survive expiration or termination of this Agreement. ARTICLE 8 - DISCLAIMER OF REPRESENTATIONS AND WARRANTIES INSTITUT CURIE AND ALL OTHER PARTIES INVOLVED IN THE CREATION, FUNDING OR PROTECTION OF THE DATA, MAKE NO REPRESENTATIONS OR EXTENDS ANY WARRANTIES EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS OF THE DATA FOR A PARTICULAR USE. WITHOUT LIMITATION OF THE FOREGOING GENERALITY, NOTHING CONTAINED HEREIN SHALL BE CONSTRUED AS EXTENDING ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE RESEARCH CONDUCTED USING THE DATA OR THE RESULTS TO BE OBTAINED HEREOF OR THAT USE OF THE DATA WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT. INSTITUT CURIE AND ALL OTHER PARTIES INVOLVED IN THE CREATION, FUNDING OR PROTECTION OF THE DATA, EXCLUDE TO THE FULLEST EXTENT PERMITTED BY LAW ALL LIABILITY FOR ACTIONS, CLAIMS, PROCEEDINGS, DEMANDS, LOSSES (INCLUDING BUT NOT LIMITED TO LOSS OF PROFIT), COSTS, AWARDS DAMAGES AND PAYMENTS MADE BY USER THAT MAY ARISE (WHETHER DIRECTLY OR INDIRECTLY) IN ANY WAY WHATSOEVER FROM THE USER’S USE OF THESE DATA OR FROM THE UNAVAILABILITY OF, OR BREAK IN ACCESS TO, THESE DATA FOR WHATEVER REASON INSTITUT CURIE AND ALL OTHER PARTIES INVOLVED IN THE CREATION, FUNDING OR PROTECTION OF THE DATA BEAR NO RESPONSIBILITY FOR THE FURTHER ANALYSIS OR INTERPRETATION OF THE DATA. ARTICLE 9 - COMPLIANCE WITH LAWS, REGULATIONS AND INSTITUT CURIE POLICIES 9.1 Compliance. User will comply with all applicable laws, rules and regulations pertaining to its use of the Data. 9.2 User represents that the conditions for use of the Data have been approved by its user Institutional Review Board (IRB), or equivalent body, in accordance with applicable law. ARTICLE 10 - MISCELLANEOUS 10.1 Amendments. Amendments to this Agreement must be made in writing and signed by authorized representatives of both Parties. 10.2 Assignment. The Agreement shall be binding on the Parties hereto and upon their respective heirs, administrators, successors and permitted assigns. This Agreement may not be assigned by either Party or by operation of law without the prior written consent of and authorized individual of the other Party. 10.3 Independent Parties. The Parties to this Agreement are independent contractors and not agents of the other. This Agreement shall not constitute a partnership or joint venture, and neither Party may be bound by the other to any contract, arrangement or understanding except as specifically stated herein. 10.4 Use of Name. Neither Party will use other Party's name or logo of any other Party in any advertising or other form of publicity without the prior written consent by an authorized individual of the other Party. 10.5 Inspection. If requested, the User will allow data security and management documentation to be inspected to verify that it is complying with the terms of this agreement. 10.6 This agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this agreement or its formation) shall be construed, interpreted and governed by the laws of France and shall be subject to the exclusive jurisdiction of the French courts.   IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Agreement as of the Effective Date. INSTITUT CURIE USER INSTITUTION By: By: Name: Name: Title: Title: Date: Date: Principal Investigator of the Registered Users, by signing below, acknowledges that he has read and understood the terms of this Agreement. By: Name: Title: Date: